Principal Clinical Trial Coordinator - FSP

Job Title: Principal Clinical Trial Coordinator - FSP Job Location: Remote, North Carolina, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Join Us as a Principal Clinical Trial Coordinator FSP– Make an Impact at the Forefront of Innovation!

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotech’s, spanning 2,700 clinical trials across 100+ countries in the last 5 years. Summary of Essential Functions: Attends kick-off meetings and supports training to team members, investigators, or clients as needed.

Serves as study eTMF lead, handling client integration and (e)TMF activities. Provides technical and administrative support for project coordination to meet study-level milestone targets. Assists with preparation and review of EDP/RCR packages. Supports development of country or site-specific documents.

Support study close-out activities including final TMF Review and TMF certification form (DEV-FORM-1939) completion.

Support with preparations for Investigator Meetings Maintaining and coordinating the logistical aspects of clinical projects and provide overall support to functional leads to ensure the successful completion of project deliverables.

Initiates the preparation of all project/program plans required by client contracts by reviewing contract and communicating with functional area leads. Coordinates project/program/protocol specific and therapeutic area training needs.

Tracks and follows up on all training, non-disclosure agreements, and security clearance requests. Performs basic project financial management tasks as assigned. Acts as task order/work assignment lead on small scopes of work for contracts/projects of low complexity.

Escalates compliance to established project-specific parameters and client expectations. As Project Specialists ensures the contracted services and expectations of assigned projects